Spasticity as Sequela of StrokePatternsNCT03588832
Prevalence of Postural Patterns of Upper Extremity.
An observational study of Spasticity as Sequela of Stroke and Stroke, run by Universidad de La Frontera at 1 site in Chile.
Trial summary
A high number of patient with stroke develops spasticity of the upper extremity, this clinical sign of damage of 1 motoneuro (MN), causes postures and patterns of abnormal movement, due to the hyperexcitability of the MN and the rheological alterations that occur in the affected muscles. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Spasticity as Sequela of Stroke, Stroke, Upper Extremity Paresis
- What is being tested?
- Evaluation Upper Extremity patterns.
- How many people
- 600 participants
- Where
- 1 siteChile
- Study dates
- 1 Jun 2018to 30 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It will consist of 600 subjects with a diagnosis of stroke who attend comprehensive rehabilitation centers in regions V, VIII, IX and X in Chile.
Who may be able to join
- Age between 20 and 85 years, with no previous history of motor disability.
- Diagnosis of ischemic or hemorrhagic stroke.
- Voluntarily accept participation in the study through the signing of informed consent, either personally or through a family member.
Who cannot join
- Presenting musculoskeletal pathology in the affected arm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Postural Patterns of Upper Extremity and Its Impact on the Quality of Life of Patients Sequelae of a Stroke.
A high number of patient with stroke develops spasticity of the upper extremity, this clinical sign of damage of 1 motoneuro (MN), causes postures and patterns of abnormal movement, due to the hyperexcitability of the MN and the rheological alterations that occur in the affected muscles. These alterations limit the use of upper extremity, restricting its use in functional activities and affecting the quality of life and social participation of the users. During the last few years the classification of the Hefter patterns for spasticity of the upper limb was created, with the end of having a common language and orienting the current therapeutic strategies oriented towards the arm.
Objective: To determine the prevalence of patterns and their impact on the quality of life of patients after a stroke.
Read more
Material and method: Descriptive design of cross section, the sample will be composed of 600 people who attend integral rehabilitation center of regions V, VIII, IX and X in Chile, that meet the inclusion criteria and sign the informed consent. The study will include a measurement made by a trained professional from each participating center using a registration form, the FIM scale and the Barthel index, to assess quality of life.
Results: It will be analyzed with the SPSS software through descriptive and inferential statistics considering the nature of the variables, all the analyzes will consider as statistically significant the results with p values less than or equal to 0.05. Depending on the interval or ordinal level of the measurements, the coefficients r of Pearson and rho of Spearman will be used to calculate the correlations.
Applicability: The results will determine the prevalence in this geographical sector, disseminate this classification and promote the use of a common language among professionals to enhance their daily work. In addition, it will allow to determine how the affectation of the upper extremity through the identification of a certain pattern alters the quality of life of the patient. This new information can be a fundamental input in the generation of future studies that seek to guide in relation to the use of therapeutic strategies in these people.
Read the detailed description
The impact generated by spasticity in the performance of functional activities in post-stroke patients is undeniable. Given the above, it is essential to evaluate this construct, considering the impact it has on the ADL. There are numerous scales that allow evaluating how spasticity affects post-stroke functionality, even helping to detect which beneficial aspects of spasticity should be considered when defining a therapeutic strategy. Among the most used scales are the Barthel Index, which assesses the level of patient independence with respect to the performance of some ADL. The scientific evidence suggests that patients with spasticity have low rates in Barthel.
The scientific evidence suggests that a careful and continuous evaluation of spasticity, would allow to identify establishment times and affected structures; as well as, to recognize predictive factors that assist rehabilitation professionals, identifying which patients are predisposed to develop spasticity, in order to reduce the risk of its establishment and influence its evolution, helping to identify preventive measures and effective interventions, that allow to achieve better motor and functional results, promoting its application in search of an optimal recovery.
Given the above, the purpose of the study is to determine the prevalence of patterns and their impact on the quality of life of patients after sequelae of a stroke. The generation of new scientific evidence acquires vital importance and are key to the management of these patients.
- Being tested
- Evaluation Upper Extremity patterns.
- Keywords
- Stroke, Spasticity, Upper Extremity, Quality of Life
- Medical subject headings
- Stroke, Paresis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation Upper Extremity patterns.Diagnostic test
Also called Evaluation upper extremity patterns after stroke.
The procedure involves evaluating subjects who meet the eligibility criteria and agree to participate in the study by signing informed consent. The study includes a measurement, applying a registration form, the Barthel scale and the FIM scale.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical record
Document created by the study team that seeks to collect clinical information from the sample, including the evaluation of the classification of patterns.
Measured: 3 months
Secondary outcomes (2)
Evaluation of Quality of life.
These will be evaluated through the:
Barthel Index that assesses the quality of life with respect to performing ADL. The values assigned to each activity depend on the time spent and help to carry it out.
The activities are valued differently, being able to assign 0, 5, 10 or 15 points. The global range can vary between 0, completely dependent, and 100 points, completely independent.
Measured: 3 months
Evaluation of functionality.
These will be evaluated through the:
Scale Functional Independence Measure (FIM) Evaluates the functional independence given through the activities of daily life (ADL). It consists of 18 items that cover two areas: motor activity (13 items) and cognitive skills (5 items). Each item is evaluated according to seven options ranging from 1 (total attendance) to 7 (total independence). The total score range goes from 18 to 126 points.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 Jun 2018
- Primary completion30 Mar 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity as Sequela of StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de La Frontera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARLETTE PATRICIA DOUSSOULIN SANHUEZA, Universidad de La Frontera
- Investigators
- Arlette P Doussoulin, PhD, Principal investigator, U Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588832
- Sponsor's protocol ID
- UFrontera
- Acronym
- Patterns
- Status last verified
- Mar 2020
- First submitted
- 26 Jun 2018
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The database will be analyzed by the principal investigator and the study methodologist.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Postural Patterns of Upper Extremity and Its Impact on the Quality of Life of Patients Sequelae of a Stroke.
- ClinicalTrials.gov ID
- NCT03588832
- Acronym / sponsor ID
- Patterns / UFrontera
- Keywords
- Stroke, Spasticity, Upper Extremity, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Universidad de La FronteraUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A high number of patient with stroke develops spasticity of the upper extremity, this clinical sign of damage of 1 motoneuro (MN), causes postures and patterns of abnormal movement, due to the hyperexcitability of the MN and the rheological alterations that occur in the affected muscles. These alterations limit the use of upper extremity, restricting its use in functional activities and affecting the quality of life and social participation of the users. During the last few years the classification of the Hefter patterns for spasticity of the upper limb was created, with the end of having a common language and orienting the current therapeutic strategies oriented towards the arm.
Objective: To determine the prevalence of patterns and their impact on the quality of life of patients after a stroke.
Material and method: Descriptive design of cross section, the sample will be composed of 600 people who attend integral rehabilitation center of regions V, VIII, IX and X in Chile, that meet the inclusion criteria and sign the informed consent. The study will include a measurement made by a trained professional from each participating center using a registration form, the FIM scale and the Barthel index, to assess quality of life.
Results: It will be analyzed with the SPSS software through descriptive and inferential statistics considering the nature of the variables, all the analyzes will consider as statistically significant the results with p values less than or equal to 0.05. Depending on the interval or ordinal level of the measurements, the coefficients r of Pearson and rho of Spearman will be used to calculate the correlations.
Applicability: The results will determine the prevalence in this geographical sector, disseminate this classification and promote the use of a common language among professionals to enhance their daily work. In addition, it will allow to determine how the affectation of the upper extremity through the identification of a certain pattern alters the quality of life of the patient. This new information can be a fundamental input in the generation of future studies that seek to guide in relation to the use of therapeutic strategies in these people.
Detailed description
The impact generated by spasticity in the performance of functional activities in post-stroke patients is undeniable. Given the above, it is essential to evaluate this construct, considering the impact it has on the ADL. There are numerous scales that allow evaluating how spasticity affects post-stroke functionality, even helping to detect which beneficial aspects of spasticity should be considered when defining a therapeutic strategy. Among the most used scales are the Barthel Index, which assesses the level of patient independence with respect to the performance of some ADL. The scientific evidence suggests that patients with spasticity have low rates in Barthel.
The scientific evidence suggests that a careful and continuous evaluation of spasticity, would allow to identify establishment times and affected structures; as well as, to recognize predictive factors that assist rehabilitation professionals, identifying which patients are predisposed to develop spasticity, in order to reduce the risk of its establishment and influence its evolution, helping to identify preventive measures and effective interventions, that allow to achieve better motor and functional results, promoting its application in search of an optimal recovery.
Given the above, the purpose of the study is to determine the prevalence of patterns and their impact on the quality of life of patients after sequelae of a stroke. The generation of new scientific evidence acquires vital importance and are key to the management of these patients.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It will consist of 600 subjects with a diagnosis of stroke who attend comprehensive rehabilitation centers in regions V, VIII, IX and X in Chile.
Key inclusion criteria (3 listed)
- Age between 20 and 85 years, with no previous history of motor disability.
- Diagnosis of ischemic or hemorrhagic stroke.
- Voluntarily accept participation in the study through the signing of informed consent, either personally or through a family member.
Key exclusion criteria (1 listed)
- Presenting musculoskeletal pathology in the affected arm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation Upper Extremity patterns.Also: Evaluation upper extremity patterns after stroke.The procedure involves evaluating subjects who meet the eligibility criteria and agree to participate in the study by signing informed consent. The study includes a measurement, applying a registration form, the Barthel scale and the FIM scale. | Diagnostic test | – |
Primary outcome
Clinical record
Time frame: 3 months
Document created by the study team that seeks to collect clinical information from the sample, including the evaluation of the classification of patterns.
2 secondary outcomes
Evaluation of Quality of life.
Time frame: 3 months
Evaluation of functionality.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Red Neurorehabilitation AraucaniaLink provided by the sponsor.
- Individual participant dataSharing planned: No. The database will be analyzed by the principal investigator and the study methodologist.
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Phenol and Botulinum Toxin vs Botulinum Toxin Alone for Post-Stroke Upper-Limb Spasticity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arlette P Doussoulin, PhD principal investigator
U Frontera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasticity as Sequela of Stroke and Stroke, run by Universidad de La Frontera at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical record (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.